COOPERS CEPRAVIN DRY COW INTRAMAMMARY ANTIBIOTIC

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Active ingredient:
CEPHALONIUM DIHYDRATE
Available from:
Intervet Australia Pty Limited
INN (International Name):
cephalonium dihydrate(89.9g/kg)
Pharmaceutical form:
MISC. INTRA MAMMARY
Composition:
CEPHALONIUM DIHYDRATE ANTIBIOTIC Active 89.9 g/kg
Units in package:
!200x3g; !50 cow; !herd pack; !Syringes; #100; #Syringes; $20x20x3g; $400; $Syringes; %32x3g; %syringes; *10x32x3g; *320; *syrin
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
CATTLE (NOT LACTATING DAIRY) | BOVINE
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
CITROBACTER FREUNDII SPP. | CORYNEBACTERIUM PYOGENES | CORYNEBACTERIUM ULCERANS | ENTEROBACTER SPP. | ESCHERICHIA COLI (E. COLI) | KLEBSIELLA SPP. | MASTITIS | PROTEUS SPP. | STAPHYLOCOCCUS AUREUS | STREPTOCOCCUS AGALACTIAE | STREPTOCOCCUS DYSGALACTIAE | STREPTOCOCCUS UBERIS | INCLUDING B-LACTAMASE PRODUCIN | SUBCLINICAL MASTITIS
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat: DO NOT USE less than 21 days before slaughter for human consumption . Milk: DO NOT USE in lactating cows or within 49 days of calving. After cal ving colosrum or milk from treated cow s MUST NOT BE USED for human consumptio n or processing for 96 hours (8 milking s).; Host/pest details: CATTLE (NOT LACTATING DAIRY): [CITROBACTER FREUNDII SPP., CORYNEBACTERIUM PYOGENES, CORYNEBACTERIUM ULCERANS, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., MASTITIS, PROTEUS SPP., STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS AGALACTIAE, STREPTOCOCCUS DYSGALACTIAE, STREPTOCOCCUS UBERIS]; For sustained, broad spectrum control of and protection against mastitis-causing bacteria (including penicillin resistant strains) in non-lactating dairy cattle. Aids in the reduction of clinical/subclinical mastitis in the subsequent lactation.Do not use in lactating cows. Do not use in cows with a dry period less than 49 days. NOT TO BE USED within 49 days of calving. Use only at the time of drying off.
Authorization status:
Registered
Authorization number:
47940
Authorization date:
2020-07-01

COOPERS

CEPRAVIN

INTRAMAMMARY

ANTIBIOTIC

47940

57968

2013

TEMPLATE

FOR

RELEVANT

LABEL

PARTICULARS

(RLPs)

(Veterinary

Products)

Select appropriate:

[J

Product (include

applicable

RLPs)

liil

Variation

(highlight instructions

that

being

varied).

Approval

label

being

varied:

[APVMA No.47940

ATS

No.

57968]

Signal

heading:

Product

name:

Active

constituenUs:

Statement

claims:

[Shorl Claim]

[Long Claim]

contents:

PRESCRIPTION

ANIMAL

REMEDY

KEEP

OUT

OF

REACH

OF

CHILDREN

FOR

ANIMAL

TREATMENT

ONLY

Coopers®

CEPRA

VIN®

DRY

COW

lntramammary Antibiotic

ACTIVE

CONSTITUENT:

CEPHALONIUM DIHYDRATE

89.9

g/kg.

HT.P

For sustained, broad spectrum control

and protection against mastitis-

causing bacteria (including penicillin-resistant strains)

non-lactating dairy

cattle.

Aids

the reduction of clinical mastitis and subclinical mastitis

subsequent lactation.

Each single dose 3g syringe contains 250mg cephalonium dehydrate in a long-

acting base.

Coopers Cepravin Dry Cow is a long-acting intramammary cerate containing

cephalonium, a semi-synthetic cephalosporin antibiotic.

It is formulated

give

effective antibiotic levels in the non-lactating udder.

Coopers Cepravin Dry Cow is recommended for dry cow therapy to treat existing

sub-clinical infections and to prevent new infections which occur during the dry

period.

Cepravin

Cow aids

reduction

clinical

mastitis

subclinical mastitis

the subsequent lactation.

Infusion at drying off should

part of a mastitis control program

the advice of your veterinary surgeon and

will reduce the risk of mastitis that may occur at calving.

Cephalonium

broad

spectrum

cephalosporin

antibiotic

which

bactericidal activity against the majority

organisms associated with bovine

mastitis.

The antibacterial activity is not impaired

the presence of milk.

Cephalonium is active against:

Staphylococcus aureus,

including penicillin

resistant strains,

Streptococcus aga/actiae, Streptococcus dysga/actiae,

Streptococcus uberis, Escherichia coli, Corynebacterium pyogenes

Corynebacterium ulcerans.

The antibiotic is also active against other

organisms recovered from the bovine udder, including

Proteus

spp.,

Klebsiella

spp.,

Citrobacter

spp. and Enterobacter strains.

20 SYRINGES

32SYRINGES

100 SYRINGES

50 COW HERD PACK

Contains:

10 X

20

X

3g

Syringes

Plus

200 TEAT WIPES

Page

, r

COOPERS CEPRAVIN

COW INTRAMAMMARY ANTIBIOTIC 47940 57968 RLP

7 Feb 2013

COW HERD PACK

Contains: 200 X 3g Syringes

Plus

200 TEAT WIPES

COW HERD PACK

Contains: 10 X 32 X 3g SYRINGES (320 SYRINGES)

Plus

TEAT WIPES

100 COW HERD PACK

Contains:

X 20 X 3g SYRINGES (400 SYRINGES)

Plus

400 TEAT WIPES

200 COW HERD PACK

Contains:

X 20 X 3g SYRINGES (800 SYRINGES)

Plus

800 TEAT WIPES

Directions for Use

READ

ACCOMPANYING

LEAFLET BEFORE USE.

Heading:

DIRECTIONS FOR USE

Restraints:

Restraints

NOT USE

lactating cows.

NOT USE

cows

with

period less than

days.

USED

within

days

calving.

accidentally

administered

within

days

calving

a lactating animal,

contact

prescribing

veterinarian

advice.

USE ONLY at

time

drying off.

Contraindications:

applicable.

Precautions:

applicable.

Side Effects:

applicable.

Page

COOPERS

CEl~u~~·~OOPE~S·CEP.RAviN''oRv'c'ow

~;di~e~~~dn

~~~r

v~;erinary

surgeon

as part

a mastitis control program.

Dosage &

Administration:

The contents

one syringe should be infused into the teat canal

each

quarter immediately after

last milking

the lactation.

Before infusion, the

teat should be thoroughly cleaned and disinfected using Cepravin

Teat

Wipes

(70% v/v isopropyl alcohol impregnated wipes)

cotton wool soaked

alcohol (seven

parts methylated spirits and three parts clean water).

Care

should

taken

avoid

contamination

syringe

nozzle

after

protective cap has been removed.

is preferable

to insert the nozzle to

its full depth -

partial insertion can reduce teat end

damage

and reduce teat

dilation.

After infusion it is advisable to dip the teats in a freshly made up

solution

a registered teat dip specifically designed for this purpose.

Wear

rubber gloves when infusing this treatment.

After milking

complete thoroughly clean and

disinfect the end

the teat (eg. with Cepravin Teat

Wipes (70% v/v isopropyl alcohol impregnated wipes

cotton wool soaked

70% alcohol (seven parts

methylated spirits and three parts clean water)).

2(i) OPTION

For short nozzle intra-mammary

administration-

hold the barrel

the syringe and the base

the cap

in one hand and twist off the small upper part

cap above the indent mark (the base portion of the

cap remains

the syringe). Take care not to

contaminate the short exposed part

the nozzle.

2(ii) OPTION

For full nozzle intra-mammary

administration -

remove the cap fully by holding the barrel

syringe firmly

one hand and with the thumb push

up and along the length

the cap until cap clicks

off.

Take care not to contaminate the nozzle.

Preferably, insert the nozzle partially into the

teat canal and apply steady pressure on the syringe

plunger until the full dose has been delivered.

Holding

the end

the teat with one hand, gently massage

upwards with the other to aid dispersion

antibiotic into the quarter.

4. Finally immerse the teats

a freshly made

up solution

a registered teat dip.

Page

COOPERS CEPRAVIN DRY COW INTRAMAMMARY ANTIBIOTIC 47940 57968 RLP V2

2013

General

Directions:

If the product is used

heifers during their first pregnancy the same restraints

and withholding

periods should

be observed as

cows.

Provided

dry cow

therapy is used, cows may

dried off safely at the end

lactation by abruptly

stopping milking when the milk yield is less than 10 litres per day.

A reduction in

food intake may

necessary. Infusion of COOPERS CEPRAVIN DRY

should

made, as described immediately after the last milking.

It is particularly important during the first

days following infusion that the cow

should not be encouraged

'let down' her milk as antibiotic may

lost.

It is

advisable, therefore, to keep recently "dried off" cows away from the milking

shed to avoid stimulating the 'let down' reflex.

For further information contact Coopers Customer Service

on

1 800 226

511.

SPECIALIST ADVICE

IN

EMERGENCY ONLY

COOPERS ANIMAL HEALTH

A Division of lntervet Australia Ply Ltd

1 800 226

511

ALL

HOURS-

AUSTRALIA WIDE

Withholding

MEAT -

DO

NOT USE

less than

21

days before slaughter for

human

Period/s:

consumption.

MILK -

DO

NOT USE

in

lactating cows or within 49 days of calving.

After

calving, colostrum or milk from treated cows MUST NOT

BE

USED for

human consumption or processing for

96

hours

(8

mil

kings).

Trade

Advice:

EXPORT SLAUGHTER INTERVAL (ESI):

This product does not have an ESI

established.

For advice on the ESI, contact Coopers Animal Health on 1 800

before using this product.

Safety

Directions:

applicable.

First

Aid:

FIRST AID:

If

poisoning occurs, contact a doctor or Poisons Information

Centre. (Phone 131126).

For further information, refer to the Material Safety Data Sheet.

Additional

User

Safety:

applicable.

Environmental

applicable.

Statements:

Disposal:

DISPOSE

empty container by wrapping with paper and putting

garbage.

Storage:

STORE

below 30°C (Room Temperature)

the closed original container

well ventilated area.

Protect from light.

Page4

COOPERS CEPRAVIN DRY COW INTRAMAMMARY ANTIBIOTIC 47940 57968 RLP V2

Feb 2013

Batch and Expiry

[Label, 20x3g]

EXPIRY

[Herd Pack

BELOW

FOR BATCH AND EXPIRY

Cartons]

Name

&

address:

COOPERS

ANIMAL

HEALTH

A division

lntervet Australia Pty Ltd

91-105 Harpin Street, Bendigo

East

VIC 3550

The following is for APVMA use only:

~:.VMA

approval

147940/57968

Page 5

Product Name: Coopers® Cepravin® Dry Cow Intramammary

Antibiotic

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 1 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Substance:

Antibiotic preparation in a long acting base.

Trade Name:

Coopers

®

Cepravin

®

Dry Cow Intramammary Antibiotic

Recommended Use:

For the treatment of and prophylaxis against mastitis in dry dairy cows.

APVMA No:

47940

Creation Date:

July, 2009

This version issued:

July, 2009

and is valid for 5 years from this date.

Statement of Hazardous Nature:

This product is classified as:

Not classified as hazardous according to the criteria of SWA.

Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

S24/25. Avoid contact with skin and eyes.

SUSDP Classification:

ADG Classification:

None allocated. Not a Dangerous Good under the ADG Code.

UN Number:

None allocated

Physical Description & Colour:

A dark blue coloured liquid in single dose syringes.

Odour:

No data.

Major Health Hazards:

no significant risk factors have been found for this product. This is an antibiotic preparation.

Any person with a history of allergies to this class of substances should avoid all contact with this product as it may cause

sensitisation.

Inhalation:

Short Term Exposure:

Available data indicates that this product is not harmful. In addition product is unlikely to

cause any discomfort or irritation.

Long Term Exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short Term Exposure:

Available data indicates that this product is not harmful. It should present no hazards in

normal use. In addition product is unlikely to cause any discomfort in normal use.

Long Term Exposure:

No data for health effects associated with long term skin exposure.

Eye Contact:

Short Term Exposure

: This product is believed to be not irritating to eyes.

Long Term Exposure

: No data for health effects associated with long term eye exposure.

Potential Health Effects

Emergency Overview

Section 2 - Hazards Identification

Section 1 - Identification of Chemical Product and Company

Intervet Australia Pty Limited

91-105 Harpin Street

Tel: 1 800 033 461

Bendigo East, Vic 3550, AUSTRALIA

Fax: 1 800 817 414

Company ABN: 79 008 467 034

Product Name: Coopers® Cepravin® Dry Cow Intramammary

Antibiotic

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 2 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Ingestion:

Short Term Exposure

: Significant oral exposure is considered to be unlikely. This product is unlikely to cause any

irritation problems in the short or long term.

Long Term Exposure

: No data for health effects associated with long term ingestion.

Carcinogen Status:

SWA:

No significant ingredient is classified as carcinogenic by SWA.

NTP:

No significant ingredient is classified as carcinogenic by NTP.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Cephalonium dihydrate

5575-21-3

89.9g/kg

not set

not set

Other non hazardous ingredients

various

to 100%

not set

not set

This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non hazardous

ingredients are also possible.

The SWA TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day for a

5 day working week. The STEL (Short Term Exposure Limit) is an exposure value that may be equalled (but should not be exceeded) for no longer than

15 minutes and should not be repeated more than 4 times per day. There should be at least 60 minutes between successive exposures at the STEL.

The term "peak "is used when the TWA limit, because of the rapid action of the substance, should never be exceeded, even briefly.

General Information:

You should call The Poisons Information Centre if you feel that you may have been poisoned, burned or irritated

by this product. The number is 13 11 26 from anywhere in Australia (0800 764 766 in New Zealand) and is

available at all times. Have this MSDS with you when you call.

Contact or Poisoning:

From the available evidence, this product would appear to offer no significant health

hazard by any exposure route. Consequently, First Aid is not generally required. If in doubt, contact a Poisons Information

Centre or a doctor.

Fire and Explosion Hazards:

There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Fire decomposition products from this product may be toxic if inhaled. Take appropriate protective measures.

Extinguishing Media

: Suitable extinguishing media are carbon dioxide, dry chemical, foam, water fog.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

Not flammable.

Upper Flammability Limit:

No data.

Lower Flammability Limit:

No data.

Autoignition temperature:

No data.

Flammability Class:

No data.

Accidental release

: This product is sold in small packages, and the accidental release from one of these is not

usually a cause for concern. For minor spills, clean up, rinsing to sewer and put empty container in garbage. Although no

special protective clothing is normally necessary because of occasional minor contact with this product, it is good practice

to wear impermeable gloves when handling chemical products. In the event of a major spill, prevent spillage from entering

drains or water courses and call emergency services.

Section 3 - Composition/Information on Ingredients

Section 4 - First Aid Measures

Section 5 - Fire Fighting Measures

Section 6 - Accidental Release Measures

Product Name: Coopers® Cepravin® Dry Cow Intramammary

Antibiotic

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 3 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Handling

: Keep exposure to this product to a minimum, and minimise the quantities kept in work areas. Check Section

8 of this MSDS for details of personal protective measures, and make sure that those measures are followed. The

measures detailed below under "Storage" should be followed during handling in order to minimise risks to persons using

the product in the workplace. Also, avoid contact or contamination of product with incompatible materials listed in Section

10.

Storage

: This product is a Scheduled Poison. Observe all relevant regulations regarding sale, transport and storage of

this schedule of poison. Protect this product from light. Store in the closed original container in a dry, cool, well-ventilated

area out of direct sunlight. Make sure that the product does not come into contact with substances listed under

"Incompatibilities" in Section 10. Check packaging - there may be further storage instructions on the label.

The following Australian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Industrial Clothing: AS2919, Industrial Eye

Protection: AS1336 and AS/NZS 1337, Occupational Protective Footwear: AS/NZS2210.

SWA Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

Exposure limits have not been established by SWA for this product.

No special equipment is usually needed when occasionally handling small quantities. The following instructions are for

bulk handling or where regular exposure in an occupational setting occurs without proper containment systems.

Ventilation:

No special ventilation requirements are normally necessary for this product. However make sure that the

work environment remains clean and that vapours and mists are minimised.

Eye Protection:

Eye protection is not normally necessary when this product is being used. However, if in doubt, wear

suitable protective glasses or goggles.

Skin Protection:

The information at hand indicates that this product is not harmful and that normally no special skin

protection is necessary. However, we suggest that you routinely avoid contact with all chemical products and that you

wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

We suggest that protective clothing be made from the following materials: latex.

Respirator:

Usually, no respirator is necessary when using this product. However, if you have any doubts consult the

Australian Standard mentioned above.

Physical Description & Colour

A dark blue coloured liquid in single dose syringes.

Odour:

No data.

Boiling Point:

Not available.

Freezing/Melting Point:

No specific data. Liquid at normal temperatures.

Volatiles:

No data.

Vapour Pressure:

No data.

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

Insoluble.

pH:

No data.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water Distribution

No data

Section 9 - Physical and Chemical Properties

Section 8 - Exposure Controls and Personal Protection

Section 7 - Handling and Storage

Product Name: Coopers® Cepravin® Dry Cow Intramammary

Antibiotic

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 4 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Autoignition temp:

No data.

Reactivity:

This product is unlikely to react or decompose under normal storage conditions. However, if you have any

doubts, contact the supplier for advice on shelf life properties.

Conditions to Avoid:

Protect this product from light. Store in the closed original container in a dry, cool, well-

ventilated area out of direct sunlight.

Incompatibilities:

No particular Incompatibilities.

Fire Decomposition:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and smoke. Nitrogen and

its compounds, and under some circumstances, oxides of nitrogen. Occasionally hydrogen cyanide gas in reducing

atmospheres. Oxides of sulfur (sulfur dioxide is a respiratory hazard) and other sulfur compounds. Most will have a foul

odour. Water. Carbon monoxide poisoning produces headache, weakness, nausea, dizziness, confusion, dimness of

vision, disturbance of judgment, and unconsciousness followed by coma and death.

Polymerisation:

This product will not undergo polymerisation reactions.

Local Effects:

Target Organs:

There is no data to hand indicating any particular target organs.

Ingredient

Risk Phrases

No ingredient mentioned in the HSIS Database is present in this product at hazardous concentrations.

Insufficient data to be sure of status. Expected to not be an environmental hazard.

Disposal:

Dispose of small quantities and empty containers by wrapping with paper and putting in garbage. For larger

quantities, if recycling or reclaiming is not possible, use a commercial waste disposal service.

ADG Code:

This product is not classified as a Dangerous Good. No special transport conditions are necessary unless

required by other regulations.

AICS:

This product is compliant with NICNAS regulations.

The following ingredient: Cephalonium dihydrate, is mentioned in the SUSDP.

This MSDS contains only safety-related information. For other data see product literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail (7

edition)

AICS

Australian Inventory of Chemical Substances

SWA

Safe Work Australia, formerly ASCC and NOHSC

Classification of Hazardous Ingredients

Section 10 - Stability and Reactivity

Section 11 - Toxicological Information

Section 12 - Ecological Information

Section 13 - Disposal Considerations

Section 14 - Transport Information

Section 15 - Regulatory Information

Section 16 - Other Information

Product Name: Coopers® Cepravin® Dry Cow Intramammary

Antibiotic

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 5 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

CAS number

Chemical Abstracts Service Registry Number

Hazchem Code

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters

IARC

International Agency for Research on Cancer

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

THIS MSDS SUMMARISES OUR BEST KNOWLEDGE OF THE HEALTH AND SAFETY HAZARD INFORMATION OF THE PRODUCT AND HOW TO

SAFELY HANDLE AND USE THE PRODUCT IN THE WORKPLACE. EACH USER MUST REVIEW THIS MSDS IN THE CONTEXT OF HOW THE

PRODUCT WILL BE HANDLED AND USED IN THE WORKPLACE.

IF CLARIFICATION OR FURTHER INFORMATION IS NEEDED TO ENSURE THAT AN APPROPRIATE RISK ASSESSMENT CAN BE MADE, THE

USER SHOULD CONTACT THIS COMPANY SO WE CAN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM OUR SUPPLIERS

OUR RESPONSIBILITY FOR PRODUCTS SOLD IS SUBJECT TO OUR STANDARD TERMS AND CONDITIONS, A COPY OF WHICH IS SENT TO

OUR CUSTOMERS AND IS ALSO AVAILABLE ON REQUEST.

Please read all labels carefully before using product.

This MSDS is prepared in accord with the SWA document “National Code of Practice for the

Preparation of Material Safety Data Sheets” 2nd Edition [NOHSC:2001(2003)]

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